Quality Manager

Page Personnel; Swansea; On-site; GBP 45,000 - 60,000; Full time

Job summary

A medical device manufacturing company in Wales is seeking a Quality Manager to lead and maintain their Quality Management System. With responsibilities including compliance with ISO standards and overseeing audits, the ideal candidate will have significant experience in quality management within the medical device industry, complemented by educational credentials in engineering or life sciences.

Benefits

Competitive salary

Performance-based incentives

Qualifications

• 5-8 years of experience in a quality management role within the medical device industry.
• In-depth knowledge of regulatory frameworks like ISO 13485 and FDA 21 CFR Part 820.
• Certification as a Lead Auditor is a plus.

Responsibilities

• Develop and maintain the Quality Management System (QMS).
• Ensure compliance with Good Manufacturing Practices (GMP).
• Oversee internal and external audits.

Skills

Knowledge of ISO 13485

Quality auditing experience

Strong problem-solving skills

Leadership skills

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree (preferred)

Tools

Statistical quality control methods

CAPA management tools

Job description

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• Become an integral part of a growing orgainsation
• Play a key role in the Quality and Regulatory function

About Our Client

The client manufacture our own branded Single-use surgical instruments, and also provide clean room contract manufacturing services for a wide range of pharmaceutical and medical device manufacturers.

Job Description

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant regulatory requirements.
• Ensure compliance with Good Manufacturing Practices (GMP) and industry-specific quality standards.
• Oversee internal and external audits, including FDA, ISO, and customer audits, and drive continuous improvement initiatives based on findings.
• Lead and manage Corrective and Preventive Action (CAPA) programs, ensuring timely resolution of non-conformities.
• Implement and maintain risk management processes in accordance with ISO 14971.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Supply Chain, to ensure product quality and regulatory compliance throughout the product lifecycle.
• Develop and execute quality control and validation strategies for processes, equipment, and software.
• Manage supplier quality management programs, including vendor audits, qualification, and performance monitoring.
• Lead training programs on quality and compliance requirements for employees.
• Oversee documentation control, ensuring proper record-keeping, traceability, and change management in compliance with regulatory requirements.

The Successful Applicant

• Bachelor's degree in Engineering, Life Sciences, or a related field. A Master's degree is a plus.
• Minimum 5-8 years of experience in a quality management role within the medical device industry.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and other regulatory frameworks.
• Experience with quality auditing, CAPA management, risk management (ISO 14971), and supplier quality assurance.
• Strong understanding of validation processes (IQ/OQ/PQ) and statistical quality control methods.
• Excellent problem-solving, leadership, and communication skills.
• Certification as a Lead Auditor, Six Sigma, or ASQ Certified Quality Engineer (CQE) is a plus.

What's on Offer

• Competitive salary and performance-based incentives